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The Acist™ CMS-2000 Angiographic Injection System with Contrast Management is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

This device is a variation of the Acist Angiographic Injector System (CL100 & CL100H). The CMS2000 is designed to be used with the CMS disposable kits. The CMS2000 and the disposable kits allow the user to maintain a reservoir of contrast between cases.

The CMS 2000 system includes an electro-mechanical powered device consisting of a power supply, pump head (syringe pump), and control panel with a disposable hand-held proportional remote control device. Also included is a disposable device containing a two port syringe body, syringe plunger, spool valve manifold, high pressure tube, three-way stopcock, pressure transducer dome, tubing, saline tubing and spike.

Contrast media, saline, and catheters are not included.

The pump head houses the electrical controls and sensing electronics for the system. together with the motors which drive the piston which controls contrast flow, and the peristaltic pump which controls saline flow. The control (console/user interface) provides control and display through a touch sensitive LCD panel, which the user may enter, control settings and monitors the operational state of the system.

The power supply houses the transformer and other filtering and power conditioning electronics for the device. The power supply is a stand-alone unit, which connects to the pump head via a cable assembly. The power supply may be remotely mounted if required.

The control panel houses a LCD display, resistive element touch screen, conditioning electronics, standby switch and speaker. The user enters injection parameters from the control panel touch screen. It connects to the injector head via a multi-conductor cable.

The hand control is connected to the display console. The hand-held control includes mechanisms for variable, proportional flow rate control and mechanisms for initiation and termination of other functions, such as saline dispense. The flow rate control provides the user with a means that can be manipulated (squeezed, moved, pushed, etc.) by the user to provide a variable command signal to the control panel to provide a continuously variable injection rate. It is expected that different configurations of the hand controller may be provided to accommodate a broad range of users.

The mounting chamber projects from the injector head. The mounting chamber is a clear material supported by a metal structure, and includes a pivoting door, reservoir holder, back light and sensing electronics.

The cart assembly contains a mechanism to assure that only CMS disposable kits are used with the CMS 2000. The cart/mounting system is a unique set of components, which allow for the attachment of the system's subsystems to each other objects depending on the application. The mounting system allows the user to optimally position subsystem components in the cath lab with a minimal amount of effort. Various mounting systems, such as bed mount and boom mount, possibly combined with a cart mount are anticipated as future system enhancements.

The provided text describes a medical device submission (510(k)) to the FDA for the ACIST CMS2000 Angiographic Contrast Management Injector System. While it details the device's description, reason for modification, and regulatory approvals, it does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to predicate devices (CL100 #K963982 and CL100H #K984058). This type of submission generally relies on comparing the new device's design, materials, and intended use to existing legally marketed devices, rather than presenting new performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information, as it is not present in the given text.

To answer your request, I would need a different type of document, such as a design verification report, a clinical study report, or a performance testing report that outlines:

• Specific acceptance criteria for the device's performance (e.g., flow rate accuracy, pressure limits, safety features).
• Details of a study conducted to test these criteria.
• The results of that study compared to the acceptance criteria.
• Information about sample sizes, data provenance, ground truth establishment, expert involvement, and comparative effectiveness if applicable.

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